Safety data sheet according to 1907/2006/EC, Article 31

Transcription

1 Page 1/7 1 Identification of the substance/mixture and of the company/undertaking Product identifier Article number: 71102, 71103, 71104, 71105, 71125, 71113, 71114, Index number: SDS Relevant identified uses of the substance or mixture and uses advised against Professional Dental Light Cure Veneer Cement Application of the substance / the mixture Professional Dental Light Cure Veneer Cement Details of the supplier of the safety data sheet Manufacturer/Supplier: Ultradent Products Inc. 505 W. Ultradent Drive (10200 S) South Jordan, UT USA onlineordersupport@utradent.com EC Responsible Person Ultradent Products GmbH Am Westhover Berg Cologne Germany infode@ultradent.com Emergency Phone: +49(0) Further information obtainable from: Customer Service Emergency telephone number: CHEMTREC (NORTH AMERICA) :(800) (INTERNATIONAL) : +(703) Hazards identification Classification of the substance or mixture Classification according to Regulation (EC) No 1272/2008 GHS07 Skin Sens. 1 H317 May cause an allergic skin reaction. Label elements Labelling according to Regulation (EC) No 1272/2008 The product is classified and labelled according to the CLP regulation. Hazard pictograms GHS07 Signal word Warning Hazard-determining components of labelling: Triethylene Glycol Dimethacrylate Hazard statements H317 May cause an allergic skin reaction. (Contd. on page 2)

2 Page 2/7 (Contd. of page 1) Precautionary statements P101 If medical advice is needed, have product container or label at hand. P102 Keep out of reach of children. P103 Read label before use. P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P280 Wear protective gloves. P362+P364 Take off contaminated clothing and wash it before reuse. P333+P313 If skin irritation or rash occurs: Get medical advice/attention. P321 Specific treatment (see on this label). P501 Dispose of contents/container in accordance with local/regional/national/international regulations. Other hazards Results of PBT and vpvb assessment PBT: Not applicable. vpvb: Not applicable. 3 Composition/information on ingredients Chemical characterisation: Mixtures Description: Mixture of substances listed below with nonhazardous additions. Dangerous components: CAS: Triethylene Glycol Dimethacrylate Skin Sens. 1, H317 >2.5-10% EINECS: Additional information: For the wording of the listed hazard phrases refer to section First aid measures Description of first aid measures After inhalation: Supply fresh air and to be sure call for a doctor. In case of unconsciousness place patient stably in side position for transportation. After skin contact: Immediately wash with water and soap and rinse thoroughly. After eye contact: Rinse opened eye for several minutes under running water. After swallowing: If symptoms persist consult doctor. Information for doctor: Most important symptoms and effects, both acute and delayed No further relevant information available. Indication of any immediate medical attention and special treatment needed No further relevant information available. 5 Firefighting measures Extinguishing media Suitable extinguishing agents: Use fire extinguishing methods suitable to surrounding conditions. Special hazards arising from the substance or mixture No further relevant information available. Advice for firefighters Protective equipment: No special measures required. 6 Accidental release measures Personal precautions, protective equipment and emergency procedures Not required. Environmental precautions: No special measures required. (Contd. on page 3)

3 Page 3/7 Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Reference to other sections See Section 7 for information on safe handling. See Section 8 for information on personal protection equipment. See Section 13 for disposal information. (Contd. of page 2) 7 Handling and storage Handling: Precautions for safe handling No special precautions are necessary if used correctly. Information about fire - and explosion protection: No special measures required. Conditions for safe storage, including any incompatibilities Storage: Requirements to be met by storerooms and receptacles: No special requirements. Information about storage in one common storage facility: Not required. Further information about storage conditions: See product labelling. Specific end use(s) Professional Dental Light Cure Veneer Cement 8 Exposure controls/personal protection Additional information about design of technical facilities: No further data; see item 7. Control parameters Ingredients with limit values that require monitoring at the workplace: The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace. Additional information: The lists valid during the making were used as basis. Exposure controls Personal protective equipment: General protective and hygienic measures: Immediately remove all soiled and contaminated clothing Wash hands before breaks and at the end of work. Respiratory protection: Not required. Protection of hands: Protective gloves The glove material has to be impermeable and resistant to the product/ the substance/ the preparation. Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/ the chemical mixture. Selection of the glove material on consideration of the penetration times, rates of diffusion and the degradation Material of gloves The selection of the suitable gloves does not only depend on the material, but also on further marks of quality and varies from manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material can not be calculated in advance and has therefore to be checked prior to the application. Penetration time of glove material The exact break through time has to be found out by the manufacturer of the protective gloves and has to be observed. (Contd. on page 4)

4 Page 4/7 Eye protection: Goggles recommended during refilling Body protection: Protective work clothing (Contd. of page 3) 9 Physical and chemical properties Information on basic physical and chemical properties General Information Appearance: Form: Viscous Colour: Shade dependent Odour: Acrylic Odour threshold: ph-value: Not applicable (non-aqueous) Change in condition Melting point/freezing point: Undetermined. Initial boiling point and boiling range: Undetermined. Flash point: >150 C Flammability (solid, gas): Not applicable. Decomposition temperature: Auto-ignition temperature: Product is not selfigniting. Explosive properties: Product does not present an explosion hazard. Explosion limits: Lower: Upper: Vapour pressure: Density at 20 C: g/cm³ Relative density Vapour density Evaporation rate Solubility in / Miscibility with water: Not miscible or difficult to mix. Partition coefficient: n-octanol/water: Viscosity: Dynamic: Kinematic: Solvent content: VOC (EC) 0.00 % Other information No further relevant information available. 10 Stability and reactivity Reactivity No further relevant information available. Chemical stability Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. (Contd. on page 5)

5 Page 5/7 Possibility of hazardous reactions No dangerous reactions known. Conditions to avoid No further relevant information available. Incompatible materials: No further relevant information available. Hazardous decomposition products: No dangerous decomposition products known. (Contd. of page 4) 11 Toxicological information Information on toxicological effects Acute toxicity Based on available data, the classification criteria are not met. LD/LC50 values relevant for classification: Triethylene Glycol Dimethacrylate Oral LD50 >5,000 mg/kg (rat) LC50 Fish 16.4 mg/l (Fish) (Toxicity to fish) Dermal LD50 >2,000 mg/kg (mouse) Primary irritant effect: Skin corrosion/irritation Based on available data, the classification criteria are not met. Serious eye damage/irritation Based on available data, the classification criteria are not met. Respiratory or skin sensitisation May cause an allergic skin reaction. CMR effects (carcinogenity, mutagenicity and toxicity for reproduction) Germ cell mutagenicity Based on available data, the classification criteria are not met. Carcinogenicity Based on available data, the classification criteria are not met. Reproductive toxicity Based on available data, the classification criteria are not met. STOT-single exposure Based on available data, the classification criteria are not met. STOT-repeated exposure Based on available data, the classification criteria are not met. Aspiration hazard Based on available data, the classification criteria are not met. 12 Ecological information Toxicity Aquatic toxicity: Triethylene Glycol Dimethacrylate Aqua toxicity 32 mg/l (daphnia) (No Observed Effect Concentration) EC50 >100 mg/l (Algae) (Toxicity to algae) Persistence and degradability No further relevant information available. Behaviour in environmental systems: Bioaccumulative potential No further relevant information available. Mobility in soil No further relevant information available. Additional ecological information: General notes: Not known to be hazardous to water. Results of PBT and vpvb assessment PBT: Not applicable. vpvb: Not applicable. Other adverse effects No further relevant information available. (Contd. on page 6)

6 Page 6/7 (Contd. of page 5) 13 Disposal considerations Waste treatment methods Recommendation Must not be disposed together with household garbage. Do not allow product to reach sewage system. Uncleaned packaging: Recommendation: Disposal must be made according to official regulations. 14 Transport information UN-Number ADR, ADN, IMDG, IATA not regulated UN proper shipping name ADR, ADN, IMDG, IATA not regulated Transport hazard class(es) ADR, ADN, IMDG, IATA Class not regulated Packing group ADR, IMDG, IATA not regulated Environmental hazards: Not applicable. Special precautions for user Not applicable. Transport in bulk according to Annex II of Marpol and the IBC Code Not applicable. UN "Model Regulation": not regulated 15 Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture Directive 2012/18/EU Named dangerous substances - ANNEX I None of the ingredients is listed. REGULATION (EC) No 1907/2006 ANNEX XVII Conditions of restriction: 3 Chemical safety assessment: Device is biocompatible when used as directed by dental professionals per ISO Other information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. Relevant phrases H317 May cause an allergic skin reaction. Department issuing SDS: Regulatory Affairs Contact: Customer Service Abbreviations and acronyms: ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous Goods by Road) (Contd. on page 7)

7 Page 7/7 IMDG: International Maritime Code for Dangerous Goods IATA: International Air Transport Association GHS: Globally Harmonised System of Classification and Labelling of Chemicals EINECS: European Inventory of Existing Commercial Chemical Substances ELINCS: European List of Notified Chemical Substances CAS: Chemical Abstracts Service (division of the American Chemical Society) VOC: Volatile Organic Compounds (USA, EU) LC50: Lethal concentration, 50 percent LD50: Lethal dose, 50 percent PBT: Persistent, Bioaccumulative and Toxic vpvb: very Persistent and very Bioaccumulative Skin Sens. 1: Skin sensitisation Category 1 (Contd. of page 6)